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FDA Denies Petition Seeking Freeze on Russia-based Applications

[ Price : $8.95]

FDA denies a citizen petition seeking a freeze on all regulatory requests from pharmaceutical and medical device companies headqua...

Surgaligns Cortera Spinal Fixation Device Cleared

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FDA clears a Surgalign Holdings 510(k) for its Cortera Spinal Fixation System.

Draft Guide on Charging for Investigational Drugs

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Federal Register notice: FDA makes available a revised draft guidance for industry entitled Charging for Investigational Drugs Und...

Panel To Discuss CDER Quality Management Proposal

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Federal Register notice: FDA announces an 11/2-3 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting to di...

GSK Opposes Teva Coreg Skinny Label Appeal

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GlaxoSmithKline asks the Supreme Court not to hear Tevas appeal of a federal appeals court decision in a case involving a so-calle...

Stakeholders Want More Drug Shortage Mitigation Info

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Two stakeholders raise questions about an FDA draft guidance on risk management plans to mitigate drug shortages.

Morton Grove Closes Business Over GMP Violations

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Morton Grove Pharmaceuticals decides to close its business as part of a federal court-approved consent decree of permanent injunct...

Woodfield Pharma President Guilty of Drug Trafficking

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Woodfield Pharmaceutical president Adam P. Runsdorf pleads guilty to drug trafficking violations in the Eastern District of Texas ...

Ways to Improve FDA Advisory Committee Process

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Harvard Medical School researchers suggest three ways FDA could improve its use of advisory committees.

FDA Updates eMDR System Enhancements

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FDA updates a Web page with enhancements to the CDRH electronic medical device reporting system.